Device for holding folding and injecting an intraocular lens

ABSTRACT

An injector ( 1 ) for folding and injecting into the eye of a patient a flexible intraocular lens, the injector comprising an assembly of an injection nozzle ( 202 ), a lens compartment that holds an unfolded flexible intraocular lens ( 400 ) and is in communication with the injection nozzle, an injector body ( 3 ) communicating with the lens compartment and a plunger ( 2 ) that is inserted in the free end of the injector body, wherein lens compartment and injector body comprise a mechanism whereby the lens is first folded by forces compressing the lens in a non-axial direction in response to an axial movement of the plunger over a first distance and is subsequently expelled from the injector through the injection nozzle in response to an axial movement of the plunger over a second distance.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a Continuation of copending application Ser. No.13/257,067, filed on Nov. 30, 2011, which claims priority under toApplication No. PCT/EP2009/053206, filed in WIPO on Mar. 18, 2008, allof which are hereby expressly incorporated by reference into the presentapplication.

FIELD OF THE INVENTION

The invention relates to a device and a method for injecting a flexibleintraocular lens which is ready to use, i.e. ready to be implanted byinjection through an incision formed in the wall of a patient's eye.

DESCRIPTION OF RELATED ART

Flexible intraocular lenses are useful, for example, in a cataractoperation in order to restore sight by a surgical procedure, whichinserts into the eye such intraocular lens, which replaces the naturallens that has become opaque due to the cataract.

Flexible intraocular lenses are often made of hydrophilic material(s)such as, for example, hydrogel, acrygel or acrylic (the latter termdeviating from its normal meaning), which materials are PMMA(polymethylmethacrylate) and/or HEMA (hydroxymethylmethacrylate),hydrated to more than 16%, in particular between 24% and 28%. U.S. Pat.No. 4,787,904 describes various examples of materials that may be usedto produce hydrophilic lenses. These lenses need to be kept in ahydrated state for conservation.

Flexible intraocular lenses can also be made from silicone materials,having a higher refractive index than hydrophilic materials, orhydrophobic acrylic materials with low glass transition temperatures.The latter materials are desirable because they typically have a highrefractive index and lenses made from them unfold more slowly and morecontrollably than silicone lenses. U.S. Pat. No. 7,157,538 describessuch a high refractive index, acrylic material used for makinghydrophobic flexible intraocular lenses.

Flexible intraocular lenses have the advantage of being able to befolded, allowing them to pass through incisions in the eye of smalldimensions. However, the problem arising with these flexible lenses isprecisely that of folding and manipulating them at the moment of thesurgical act. U.S. Pat. No. 4,787,904 proposes to conserve a hydrophiliclens in a folded state in the injection device while being immersed in aconserving solution, the whole assembly being contained in a flexiblepackaging pocket. However, this method may not be used in practice,since a lens which has remained folded for a long period may retain ashape memory of the folded state and therefore does not regain itsunfolded, functional shape after implantation.

As a result, hydrophilic lenses up to now have been conserved flat insterilized rigid containers of conserving solution. At the moment of thesurgical act, the surgeon removes the lens using a pincer, folds it(optionally with the aid of a folding device) or places it in a foldingcartridge or in an injector and injects it into the eye. Thesemanipulations are relatively complex and delicate, increasing the riskof contamination and damage to the lens.

U.S. Pat. No. 6,386,357 discloses a soft intraocular lens-folding devicecomprising a base member with a tapered slide groove portion, and amovable member comprising an elastically bendable pair of legs and acommon base connecting the pair of legs. A soft intraocular lens isintroduced in the lens-receiving portion of the movable member, the lensbeing clamped by wall portions. The lens is folded by moving the movablemember into the groove portion in the base member, forcing the legs ofthe movable member to be drawn near to one another. This document doesnot disclose any means for injecting the folded lens.

U.S. Patent Publication No. 2005182419 discloses an injector for anintraocular lens comprising an injector housing with an intraocular lensdisposed in the housing. The injector further comprises a lens carrier,which, in response to an actuator, engages and moves the lens within anarrowing injection nozzle in order to fold the lens. A plunger is thenused to advance the folded lens and inject it into a patient's eye.Here, folding and injection of the lens cannot be achieved by a single,continuous movement of a plunger, adding complexity to the surgicalprocedure.

BRIEF SUMMARY OF THE INVENTION

The present invention is to provide a device and a method for injectinga flexible intraocular lens through an incision formed in the wall of apatient's eye, where the lens is reproducibly folded before it isinjected.

The aims of the present invention are achieved, among others, by aninjector for folding and injecting into the eye of a patient a flexibleintraocular lens, the injector comprising an assembly of an injectionnozzle, a lens compartment that holds an unfolded flexible intraocularlens and is in communication with the injection nozzle, an injector bodycommunicating with the lens compartment and a plunger that is insertedin the free end of the injector body, wherein lens compartment andinjector body comprise a mechanism whereby the lens is first folded byforces compressing the lens in a non-axial direction in response to anaxial movement of the plunger over a first distance and is subsequentlyexpelled from the injector through the injection nozzle in response toan axial movement of the plunger over a second distance.

In another embodiment of the lens injector of the invention, the lenscompartment is integrated in the injector body.

In a particular embodiment of the invention, the injector comprises:

-   -   a) a hollow injector body comprising a distal flange and a        proximal end piece comprising an opening for insertion of a        plunger,    -   b) a lens compartment consisting of a support guide and a lens        support, the support guide consisting of an open hollow        structure having side walls defining a tapered internal shape        with the wider proximal end of the structure being mounted on        the distal flange of the injector body and the narrower distal        end of the structure being left unobstructed/unattached to        provide an opening for passage of an injection nozzle, and the        lens support comprising a pair of parallel wedge plates of        tapered shape dimensioned to be capable of abutting the side        walls of the support guide when positioned within the support        guide near its distal end, the parallel wedge plates being        connected at their narrow extremity to the injection nozzle, and        a pair of folding members pivotally connected to the wedge        plates at their narrow extremity, the wedge plates and the        outward pivoted folding members defining an internal support        cavity that holds a flexible intraocular lens in an unfolded        state, the lens support being placed within the support guide at        a distance from its distal end and essentially abutting the        distal flange of the injector body,    -   c) a plunger guide disposed within the injector body with its        distal end contacting the lens support, and    -   d) a plunger inserted partially in the injector body through an        opening at the proximal end of the injector body with the        inserted end of the plunger being reversibly held within the        plunger guide,        where, in response to axial movement of the plunger over a first        distance, the plunger guide and the lens support are advanced by        the same distance, whereby through interaction with the tapered        side walls of the support guide the folding members of the lens        support are forced to pivot inward to fold the intraocular lens        in a direction essentially perpendicular to the injection axis        and the plunger guide acquires an alternative configuration        permitting movement of the plunger within the plunger guide and        where, in response to axial movement of the plunger over a        second distance, the folded lens is being advanced by direct        contact with the plunger through the distal end of the support        cavity and the injection nozzle from which the lens emerges.

In another embodiment of the invention, the support guide comprisessloped ridges sloping toward one another from the support guide proximalend to the support guide distal end of the support guide, and wherebythrough interaction with the sloping ridges the folding members areforced to pivot inward to fold the intraocular lens in a directionessentially perpendicular to the injection axis.

The injector may additionally comprise an end cap fixedly put on theflange of the injector body, thereby encasing the lens support.

In a more particular embodiment of the injector according to theinvention, the plunger guide is reversibly attached to and moves withthe plunger when the latter is moved over the first distance whereby thelens support is advanced within the support guide, and detaches from theplunger when the latter is moved further over the second distance, theplunger then being able to move freely within the plunger guide wherebythe lens is driven out of the injection nozzle.

In another embodiment of the invention, the plunger guide comprises apair of flexible legs connected on the distal side of the plunger guideby a connecting portion, the free end of each leg comprising a stoppiece, and wherein the plunger comprises clipping means, able to clip onthe stop pieces when the legs are in a closed position, attaching theplunger to the plunger guide, and able to be unclipped when the legs arein an open position, detaching the plunger from the plunger guide.

In yet another embodiment of the invention, the clipping means are twoopposite snap hooks able to engage on the distal edge of the stoppieces.

In yet another embodiment of the invention, the injector body comprisesa first portion and a second portion, the legs of the plunger guidebeing in the closed position when the plunger guide is at least partlypositioned within the second portion, and the legs being in the openposition when the plunger guide is positioned completely within thefirst portion.

In yet another embodiment of the invention, the length of the second andfirst portion corresponds, respectively, to the first and seconddistance.

In yet another embodiment of the invention, the internal section of thesecond portion is such as to force the legs of the plunger guide to bein the closed position and the first portion has an internal sectionlarger than the one of the second portion allowing the legs to regaintheir unstressed open position.

In yet another embodiment of the invention, each folding membercomprises a notch at its distal extremity, the notch being able to abutagainst the edge of the injection nozzle in order to pivotally mount thefolding member in the lens support.

In yet another embodiment of the invention, the folding members arefixed by their distal extremity to the external wall of the injectionnozzle with a flexible link.

In yet another embodiment of the invention, the support guide comprisestwo sloped ridges destined to cooperate with the folding members,forcing them to fold until they become essentially parallel to theinjection axis as the lens support is advanced within the support guideover the first distance.

In yet another embodiment of the invention, each folding membercomprises a protruding element (e.g., a nose) on the side opposite tothat forming the lens cavity, which element cooperates with the slopedridges.

In yet another embodiment of the invention, a plug is held at the distalend of the plunger, the plug being able to drive the lens when theplunger is moved over the second distance.

In yet another embodiment of the invention, the plug is made from a softand flexible material.

In yet another embodiment of the invention, the distal end of theplunger has the shape of a two-toothed fork destined to hold the plug.

In yet another embodiment of the invention, the lens support and thesupport guide comprise through holes destined to the filling of theinternal support cavity with a viscoelastic solution.

In yet another embodiment of the invention, the end piece comprises atoric joint, the end piece being fixed sealing fluidly on the injectorbody and the opening being able to guide the plunger passing through it.

In yet another embodiment of the invention, the lens support isfabricated in one piece by an injection plastic molding process.

The present invention also encompasses a method for assembling areinjector of the invention, the method comprising the steps of:

-   -   a) disposing tonic joint and, optionally, the end piece on the        plunger and, optionally, mounting a flexible plug at the distal        end of the plunger;    -   b) inserting the plunger into the injector body through the end        piece of the injector body;    -   c) inserting the plunger guide within the injector body;    -   d) disposing the intraocular lens unfolded within the internal        support cavity of the lens support, and mounting the lens        support on the plunger guide;    -   e) fixing the support guide and the end cap on the injector        body;    -   f) optionally introducing a sufficient volume of an aqueous        solution though an opening in the end piece of the plunger to        keep the lens wetted;    -   g) fixing toric joint and sleeve portion on the end piece of the        injector body; and    -   h) optionally packaging the injector in a sealable flexible        packaging, sealing the container and sterilizing the packaged        injector.

In a particular embodiment of the assembly method, in step d) a lenshaving two opposing haptics is disposed within the internal supportcavity with the two haptics being oriented along the injection axis.

The present invention also encompasses a method for injecting anintraocular lens using an injector of the invention, comprising thesteps of:

-   -   a) removing the end cap from the flange of the injector body;    -   b) depressing the plunger over a first distance in order to        advance the lens support within the support guide and fold the        lens along the injection axis; and    -   c) depressing the plunger over a second distance in order to        drive the lens outside of the injection nozzle.

In an embodiment of the injection method, the injector is removed fromits packaging during a preliminary step.

In another embodiment of the injecting method, a viscoelastic solutionis introduced within the internal support cavity prior to step b) of theabove-described injection method.

In yet another embodiment of the injection method, the viscoelasticsolution is introduced within the internal support cavity through holesprovided in wedge plates of the lens support and the support guide,respectively, or through the injection nozzle.

In the present description of the invention, the expressions “distalend” or “distal extremity” signify the end on the side of the injection,while the expression “proximal end” signifies the opposite side.

BRIEF DESCRIPTION OF THE DRAWINGS

The invention will be better understood with the aid of the descriptionof an embodiment given by way of example and illustrated by the figures,in which:

FIG. 1 represents an injector comprising an end cap, an injector body, aplunger, according to an embodiment of the invention;

FIG. 2 represents a partial view of the injector of FIG. 1 where the endcap has been removed, showing a support guide;

FIG. 3 represents another partial view of the injector where end cap,injector body, and support guide have been removed, showing a lenssupport, a plunger guide and a plunger;

FIG. 4 shows an isolated view of a plunger and a lens support;

FIG. 5 shows an isolated view of a lens support with wedge plate, a pairof folding members and an injection nozzle;

FIG. 6 shows another isolated view of the lens support with the pair offolding members being pivotally mounted;

FIG. 7A shows an isolated perspective view of the lens support mountedwithin the support guide seen from the plunger side, according to anembodiment of the invention;

FIG. 7B shows a section view along the line C-C of FIG. 7A;

FIG. 8 shows an intraocular lens being disposed within the lens support,according to an embodiment of the invention;

FIG. 9 illustrates the intraocular lens being completely folded withinthe lens support, according to an embodiment of the invention;

FIG. 10 represents the injector of the invention, viewed from itsproximal end; and

FIG. 11 shows the end cap viewed from its proximal end.

DETAILED DESCRIPTION OF EMBODIMENTS OF THE INVENTION

An injector 1 according to an embodiment of the invention is representedin FIGS. 1, 2 and 3. The injector 1 comprises a plunger 2, extendingalong a longitudinal axis corresponding to the injection axis A, withina hollow cylindrical injector body 3. In the example of FIGS. 1 and 2,the injector body 3 comprises two opposite wing-shaped finger tabs 4,extending essentially perpendicular to the injection axis A and mountedon the injector body 3. Different configurations of the injector body 3and finger tabs 4 are also possible as long as the injector body 3 isprovided with means against which the fingers of a user can bear. Inanother example not represented, the injector body 3 can comprise twopairs of opposite finger tabs mounted on the injector body 3 on aradially extending support structure.

The injector body 3 is closed at its proximal end by an end piece 6comprising an opening 7 in which the plunger 2 is introduced and guided.The end piece 6 has a sleeve portion 8 arranged to be fixed by snap-fitinto the proximal end of the injector body 3. A first tonic joint 9 (seeFIG. 3) is accommodated in the end piece 6 in order to seal fluidly theend piece 6 on the injector body 3 and the opening 7 with the plunger 2passing through it. The tonic joint 9 may be formed of any flexibleelastomeric material.

At its distal end, or at the end opposite to the end piece 6, theinjector body 3 comprises an oval-shaped flange portion 10 extendingessentially perpendicular to the injection axis A. Flange 10 comprises acollar portion 12 (see FIG. 2), extending in the axial direction frompart 10. Other configurations of the flange 10 are also possible. Forexample, flange 10 can have a circular, an elliptical or a rectangularshape and can be supported on the injector body 3 with support elements(not represented).

In an embodiment of the invention, the injector body 3 comprises a firstportion 16 having a first internal diameter and extending from theflange 10 to a second portion 17 having a second internal diameter thatis smaller than the first internal diameter (FIG. 2). The injector body3 also comprises a third portion 18, having an internal smaller than theone of the second portion 17, and extending between the second portion17 and the end piece 6.

In FIG. 1, the injector 1 comprises an end cap 13 able to be fixedly puton flange 10 using two clips 14, located on opposing positions on theend cap 13 and engaging on the face of flange 10, opposed to the end cap13, or by any other fixation means. A second tonic joint 11 (see FIG. 2)placed around the outer wall of the collar portion 12 insures the liquidtightness between the end cap 13 and flange 10.

The injector 1 also comprises a lens compartment consisting of a supportguide 100 and a lens support 200 (see FIG. 3). FIG. 2 represents theinjector 1 where the end cap 13 has been removed from the injector body3, showing the support guide 100 fixed on the flange 10. The supportguide 100 is an open hollow structure having side walls defining atapered internal shape, a narrower, truncated support guide distal end101, and a wider proximal end 102 having an oval section, or any sectionconformal with the internal periphery of the collar portion 12. Thesupport guide 100 can be mounted and fixed on the flange 10 bypress-fitting its proximal end 102 within the internal periphery of thecollar portion 12. In the example of FIG. 2, the support guide 100contains a guiding pin 103 fitted in a corresponding indentation 15 inthe collar portion 12, insuring a better positioning and fixation of thesupport guide 100 on the flange 10. Holes 107 are provided in thesupport guide 100 in order to allow for the introduction of aviscoelastic solution within the lens support 200 as will be explainedbelow. In the example of FIG. 2, the holes 107 are accessible throughindentations 15 let into the collar portion 12.

In an embodiment of the invention, the injector body 3 is fabricated inone piece with an injection plastic molding process.

Plunger and Plunger Guide

FIG. 3 represents another partial view of the injector 1 from which theinjector body 3, the end cap 13, and the support guide 100, have beenremoved. FIG. 3 shows the plunger 2 extending between the end piece 6,with its tonic joint 9, and the lens support 200, placed underneath thesupport guide 100 illustrated in FIG. 2. Also visible in FIG. 3 is aplunger guide 300, disposed within the injector body 3 and extendingbetween the internal wall of the injector body 3 and the plunger 2. Theplunger guide 300 comprises a pain of flexible legs 301 of hollowsemi-oval shape, the legs 301 being connected on the distal side of theplunger guide 300, or on the side of the lens support 200, by aconnecting portion 302 integrally formed with the legs 301. The legs 301each comprise a protruding stop piece 303 at their respective free ends.

In FIG. 3, the legs 301 are shown in an unstressed open positionallowing the plunger 2 to move axially within the plunger guide 300. Theplunger guide 300 also comprises two opposite ribs 304, extending alongits whole length. The ribs 304 are guided in corresponding grooves (notshown) provided in the internal wall of the injector body 3, when theplunger guide 300 is inserted within the injector body 3, and used toorient radially and guide axially the plunger guide 300 within theinjector body 3.

FIG. 4 shows an isolated view of the plunger 2 with the lens support 200disposed at the distal end 22 of the plunger 2. The plunger 2 haspreferably an elliptical or ovoid section but can have any othersuitable section shape such as a circular, square or rectangularsection. The plunger 2 also comprises clipping means. In the example ofFIG. 4, the clipping means are two snap hooks 19 that are oppositelydisposed on the plunger 2, each at a position corresponding to that oneof a stop piece 303 of the plunger guide 300.

Lens Support

The lens support 200 according to an embodiment of the invention isrepresented in the perspective views of FIG. 5 and FIG. 6. The lenssupport 200 comprises a pair of parallel wedge plates 201 of taperedshape and connected, at their narrow extremity, to an injection nozzle202. The injection nozzle 202 is terminated by a nozzle distal end 203destined to be introduced in an incision formed in the wall of apatient's eye during lens replacement surgery. The interior of theinjection nozzle 202 forms a nozzle canal 204.

The lens support 200 also comprises a folding device for folding thelens 400 in a direction essentially perpendicular to the injector axisin response to axial movement of the plunger 2 as exemplified in FIGS. 8and 9. In the example of FIGS. 5 and 6, the folding device is a pair offolding members 205 being fixed by their distal extremity, which is theextremity on the side of the injection nozzle 202, to the external wallof the injection nozzle 202 with a flexible link 206. The foldingmembers 205 comprise a notch 207 at their distal extremity. The pair offolding members 205 can be pivotally mounted by abutting theirrespective notches 207 against edges of the injection nozzle 202, asshown in FIG. 6. The spacing between the two wedge plates 201 allows thefolding members 205 to pivot within the two plates 201 while beingguided laterally by the plates 201. When the two folding members 205 arein an open position as shown in FIG. 6, the two wedge plates 201 and thefolding members 205 delimit an internal support cavity 208.

The wedges plates 201 also comprise a tail-shaped part 209, extendingalong the plunger 2 and within the plunger guide 300 as shown in FIG. 3.The internal surface of the tail-shaped part 209 forms a groove 210extending along the injection axis A on the internal surface of thewedge plates 201, forming an injection canal that extends the nozzlecanal 204 of the injection nozzle 202. Two ribs 211 extend along theinjection axis A, on the tail-shaped part 209 and the two oppositeexternal surfaces of the wedge plates 201 of the lens support 200.

Support Guide

FIGS. 7A and 7B show an isolated view of the support guide 100 accordingto an embodiment of the invention. In FIG. 7A, the support guide 100 isseen from the plunger side, and a section view along the line C-C ofFIG. 7A is represented in FIG. 7B. In FIG. 7B, the lens support 200 isalso shown with pivoted folding members 205.

The support guide 100 comprises two internal lateral sloped ridges 106,formed within the internal surface of the support guide 100 and slopingtoward one another from the support guide proximal end 102 to thesupport guide distal end 101 of the support guide 100. These slopedridges 106 are destined to cooperate with the folding members 205 aswill be explained below.

In the example of FIGS. 7A and 7B, the internal surface of the supportguide 100 also comprises two guiding slots 104 extending along bothsides of the support guide 100, and adapted to guide laterally themovement of the lens support 200 within the support guide 100 along theinjection axis A. The two ribs 211 press against two parallel guidingfaces 105, extending along the injection axis A and oppositely disposedon the internal upper and lower surfaces of the support guide 100, inorder to laterally guide the lens support 200 advancing within thesupport guide 100. Alternatively, the two ribs 211 can also pressagainst two parallel guide ribs (not represented), extending along theinjection axis A and oppositely disposed on the internal upper and lowersurfaces of the support guide 100.

Other configurations of the support guide 100 are also possible. Forexample, the guiding slots 104 can be replaced by a pair of ribs inorder to guide laterally the movement of the lens support 200 within thesupport guide 100 along the injection axis A.

The lens injectors of the present invention and their various pans mayfabricated from different types of plastic materials. For example, theinjector body may be produced from polycarbonate (PC), polyetherimide(PEI) or polysulfone (PSU), the end cap from PC, PEI or polyamide (PA),the plunger from PC, PEI or PSU, the support guide from PP, PC,polybutylene-terephtalate (PBT) or polyoxymethylene (POM), the lenssupport from POM, PP, BC, PA, PEI or polyethylene-terephtalate (PET),the plunger guide from PA, PBT or polypropylene, the plug from siliconeor a vulcanized thermoplastic material, and the toric joints fromsilicone.

Assembling the Injector

When assembling the injector 1, the end piece 6 and the toric joint 9are first disposed on the proximal end of the plunger 2. Here, theplunger 2 is inserted into the end piece 6 through the opening 7. Theplunger 2 is then inserted into the injector body 3. The two snap hooks19 of the plunger 2 are arranged such as to be able to pass through thethird portion 18 of the injector body 3, and abut against the distal endof portion 18 once the hooks 19 have passed this portion 18, preventingthe plunger 2 from moving backward. Preferably, the end piece 6 is notyet clipped on the proximal end of the injector body 3.

In a preferred embodiment of the injector of the invention, a flexibleplug 20 is subsequently mounted on the distal end of plunger 22. Theplug 20 is preferably made from a soft and flexible material, in orderto avoid scratching of the lens 400 during the injection operation.Here, the distal end of the plunger 2 can comprise a forked distal end22, as shown in FIG. 4, allowing the flexible plug 20 to extend at leastpartially in between the two teeth of the distal end 22. Otherconfigurations of the distal end 22, that abuts the plug 20, are alsopossible. It is noted that plug 20 may be added to the plunger end 22 ata later stage, but prior to the mounting of the lens support 200 on theplunger guide 300.

The plunger guide 300 is next mounted within the injector body 3. Thetwo opposite ribs 304 of the plunger guide 300 are guided within thecorresponding grooves of the injector body 3 allowing the plunger guide300 to be introduced into the desired angular position within theinjector body 3. When the plunger guide 300 reaches its full rearposition, it is forced into its closed position, the clipping means ofthe plunger 2, here the two snap hooks 19, are able to engage on thedistal edge of the stop pieces 303, reversibly connecting the plungerguide 300 and the plunger 2.

The respective internal diameters of the portions 16, 17, 18 are such asto allow the plunger guide 300 to be introduced within the first andsecond portions but not within the third portion 18. The plunger guide300 introduced within the injector body 3 from the flange 10 side thusabuts against the end of the second portion 17, adjacent to the thirdportion 18. In this initial position, the plunger guide 300 extendsalong the first and second portions 16, 17. The internal diameter of thesecond portion 17 is such as to force the two opposite stop pieces 303of the legs 301 to come in contact with the two snap hooks 19, theplunger guide 300 being thus in a closed position. When, in response toa forward movement of the plunger, the plunger guide is advanced out ofthe second portion 17 and into the first portion 16, the plunger guide300 is able to regain its unstressed open position.

Other configurations of the injector body 3 are also possible, as longas they provide a configuration that enables the plunger guide 300 to beeither in a closed position or in an unstressed open position, dependingon the axial position of the plunger guide 300 within the injector body3. For example, the injector body 3 can have a uniform internal diameteralong its whole length but comprise internal ribs distributed around itsinternal wall, the ribs having a height that varies between sectionsalong the injector body 3.

An intraocular lens 400 is then disposed unfolded between the two wedgeplates 201, within the internal support cavity 208 (FIG. 6; FIG. 8).Preferably, the lens 400 is disposed within the internal support cavity208 with their two haptics 401 being oriented along the injection axisA, as shown in FIG. 8.

The lens support 200 containing the lens 400 is then mounted on theplunger guide 300 by inserting the tail-shaped part 209 within theconnecting portion 302 of the plunger guide 300 (FIG. 3; FIG. 6). Inthis position, the two folding members 205 are prevented from pivotingon the intraocular lens 400 by abutting against two protrusions 23located on the flange 10 of the injector body 3 (see FIG. 8). Also shownin FIG. 8 are two protruding members 21 arranged to maintain theunfolded lens 400 within the lens support 200 in its unfoldedorientation as described above, until the lens 400 is folded andejected. The protruding members 21 do not prevent the pivoting of thetwo folding members 205.

The support guide 100 is then fixed on flange 10 of the injector body 3and the end cap 13 is clipped on the flange 10 after placing the secondtoric joint 11 around the external periphery of the collar portion 12(FIG. 1; FIG. 2). The second toric joint 11 could also be placed at anyother injector assembly steps, before the step of clipping the end cap13 on the flange 10, described below.

In the case of a flexible hydrophilic intraocular lens, the end cap 13and the injector body 3 are filled with an aqueous solution such as asaline solution, distilled water, or any other aqueous solution adequatefor keeping the intraocular lens 400 wet. The aqueous solution may beintroduced through filling openings, in the proximal end of the injectorbody 3 by means of a syringe. Such two openings 27 are shown in theexample of FIG. 10 representing the injector 3 viewed from its proximalend.

The aqueous solution fills at least partly the volume enclosed by theend cap 13, lens support 200 and injector body 3. In the case a flexiblehydrophobic intraocular lens is used, there is no need for a bathingsolution and the step of filling the injector body 3 and the end cap 13with an aqueous solution may be omitted.

When the end cap 13 is fixed on the injector body 3, the lens support200 abuts against the end cap 13 and the plunger 2 cannot be depressed.

In a preferred embodiment of the invention shown in see FIG. 11representing the end cap 13 viewed from its proximal end, the end cap 13comprises a central hollow tube 24 extending along the injection axis Atoward the injector body 3. When the end cap 13 is fixed on the injectorbody 3, the distal end 215 of both opposite support ribs 211 of the lenssupport 200 abuts against the proximal end 25 of the central tube 24. Inthis configuration, the plunger 2 cannot be moved backward due to thesnap hooks 19 abutting against the distal end of portion 18, asdescribed above. Consequently, any false manipulation of the plunger 2prior to the injection operation is avoided.

After fixing the end cap 13, the toric joint 9 is placed on a grove 26on the proximal end of the injector body 3 (see FIG. 9) and the endpiece 6 is clipped on said proximal end, making the interior of theinjector body sealed. The injector 1 is then ready to be packaged into asealable flexible packaging (not represented) such as a sleeve orblister, or any other packaging. After the packaging is sealed, thepackaged injector 1 is subjected to sterilization. A preferred method ofsterilization is steam sterilization (autoclaving).

Using the Injector

Prior to the injection operation, the injector is separated from itspackaging, and the end cap 13 is unclipped and removed from the flange10, causing the aqueous solution to drain from the injector body 3 andthe lens support 200. In order to keep the lens 400 and lens support 200lubricated during the injection operation, a viscoelastic solution suchas a solution containing hyaluronic acid, chondroitin sulfate or acellulose derivative such as hydroxypropylmethylcellulose (EIPMC) can beintroduced within the internal support cavity 208 through holes 212provided in the wedge plates 205 and the corresponding holes 107 of thesupport guide 100, for example, by using a syringe. Alternatively or inaddition, the viscoelastic solution can also be introduced through thenozzle distal end 203 of the injection nozzle 202. The holes 107 and212, and the nozzle distal end 203 also increase the fluidiccommunication within the end cap 13, facilitating the penetration ofaqueous wetting solution into the lens support 200.

During an injection operation, the plunger 2 is depressed causing theplunger guide 300 to move forward over a first distance, advancing thelens support 200 within the support guide 100 along the injection axisA. During the advance of the lens support 200, the sloped ridges 106 ofthe support guide 100 force the pair of folding members 205 to pivottoward the injection axis A, drawing them near to one another until theybecome essentially parallel to the injection axis A, transforming theinternal support cavity 208 into an injection canal 213 that extendsalong the folded folding members 205 and into the nozzle canal 204 ofthe injection nozzle 202. The lens support 200 advances in the supportguide 100 until it abuts against the support guide 100 and cannotadvance further.

In an embodiment of the invention not represented, during the advance ofthe lens support 200 within the support guide 100, the folding members205 of the lens support 200 interact with the internal tapered sidewalls, forcing the folding members 205 to pivot inward and fold theintraocular lens in a direction essentially perpendicular to theinjection axis A.

The above operation causes the intraocular lens 400 to fold, the lens400 being folded or rolled in a direction essentially perpendicular tothe injection axis A as shown in FIG. 7B, when completely folded.Consequently, the folded lens 400 is ready to be advanced axially intothe nozzle canal 204.

In an embodiment of the invention, each folding member 205 comprises aprotruding element 214. When the lens support 200 advances within thesupport guide 100, the sloped ridges 106 press against the protrudingelements 214, and pivots the pair of folding members 205 toward theinjection axis A, as described above. The protruding elements 214 canadvantageously enhance the angular distance the folding members 205 willtravel within the lens support 200 during the forward motion of the lenssupport within the support guide 100. Moreover, the use of protrudingelements 214 can also reduce the friction during the advancement of thelens support 200 within the support guide 100, compared to a contactmade along the whole folding member 205.

When the plunger 2 has moved over the first distance and the lenssupport 200 reached its abutting position within the support guide 100,the plunger guide 300 has moved completely outside the second portion 17and extends only within the first portion 16 of the injector body 3 andwithin the support guide 100. It is noted that once plunger guide 300has moved outside of second portion 17, it cannot be returned to itsinitial position within portion 17, thereby preventing an unfolding ofthe folded lens as a consequence of an accidental retraction of plunger2. The diameter of the first portion 16 is large enough to allow the twolegs 301 of the plunger guide 300 to regain their unstressed position,in which the two legs 301 are slightly bent apart, enabling the plungerguide 300 to be detached from the plunger 2, allowing the plunger 2 tomove freely within the plunger guide 300 and advance within it.

When operator pressure continues to be applied, the plunger 2 and plug20 advance over a second distance and propel the folded lens 400 alongthe injection canal 213, and outside the nozzle distal end 203, enablingthe lens 400 to be injected into the patient's eye (see FIG. 9). Theflexible plug 20 is able to follow conformably the varying dimensions ofthe internal support cavity 208 formed by the two folding members 205and the nozzle canal 204, avoiding the necessity of requiring accuratedimensions for the different parts forming the compressed support cavity208 and the nozzle canal 204.

In an exemplary embodiment of the invention, the lens support 200 isable to advance in the support guide 100 over a distance of about 15 mm,this distance corresponding to the length of the second portion 17 ofthe injector body 3. Here, the total length formed by the first andsecond portions 16, 17 corresponds essentially to the length of theplunger guide 300.

In an embodiment of the invention, the lens support 200, comprising thetwo wedge plates 201, the injection nozzle 202, the two folding, members205 and links 206, is fabricated in one piece by an injection plasticmolding process.

SYMBOLS AND REFERENCES

-   1 injector-   2 plunger-   3 injector body-   4 finger tab-   6 end piece-   7 opening-   8 sleeve portion of the end piece-   9 tonic joint-   10 flange-   11 second toric joint-   12 collar portion-   13 end cap-   14 clip-   15 indentations-   16 first portion-   17 second portion-   18 third portion-   19 snap hook-   20 plug-   21 protruding member-   22 distal end of the plunger-   23 protrusions-   24 central hollow tube-   25 proximal end of the central tube-   26 groove-   27 filling opening-   100 support guide-   101 support guide distal end-   102 support guide proximal end-   103 guiding pin-   104 guiding slot-   105 guide ribs-   106 sloped ridge-   107 holes in the support guide-   200 lens support-   201 wedge plate-   202 injection nozzle-   203 nozzle distal end-   204 nozzle canal-   205 folding member-   206 link-   207 notch-   208 internal support cavity-   209 tail-shaped part-   210 groove-   211 support rib-   212 holes in the wedge plates-   213 injection canal-   214 protruding element-   215 distal end of support rib-   300 plunger guide-   301 legs of the plunger tilde-   302 connecting portion-   303 stop piece-   304 rib-   400 intraocular lens-   401 haptic-   A injection axis

The invention claimed is:
 1. An injector for folding and injecting into an eye of a patient a flexible intraocular lens, the injector comprising: an injection nozzle; a support guide around the injection nozzle; a lens support having a plate and a pair of folding members, each folding member having a first end attached to the injection nozzle and a second end; a lens compartment in communication with the injection nozzle; and an injector body communicating with the lens compartment and a plunger that is inserted in a free end of the injector body, the plunger extending through the injector body, wherein each folding member pivots about an axis that is perpendicular to a longitudinal direction of the injector body, and wherein, upon movement of the plunger, the support guide presses the second end of each folding member inward toward a longitudinal axis of the plunger to compress a lens.
 2. The injector according to claim 1 wherein the lens compartment is integrated in the injector body.
 3. The injector according to claim 1, wherein the injector comprises an end cap fixedly put on a distal flange of the injector body, thereby encasing the lens support.
 4. The injector according to claim 1, wherein the support guide comprises two sloped ridges destined to cooperate with the folding members, forcing the folding members to fold until they become essentially parallel to the longitudinal axis of the plunger.
 5. The injector according to claim 4, wherein each folding member comprises a protruding element cooperating with the sloped ridges.
 6. The injector according to claim 1, wherein the lens support and the support guide comprise through holes destined to the filling of an internal support cavity with a viscoelastic solution.
 7. The injector according to claim 1, further comprising an end piece on the injector body, the end piece having an opening, wherein the end piece comprises a tonic joint, the end piece being fixed sealing fluidly on the injector body and the opening being able to guide the plunger passing through it.
 8. A method for injecting an intraocular lens using an injector according to claim 1 and comprising the steps of: a) removing an end cap from a distal flange of the injector body; b) depressing the plunger over a first distance in order to advance the lens support within the plunger guide and fold the lens along the longitudinal axis (A); and c) depressing the plunger over a second distance in order to drive the lens outside of the injection nozzle.
 9. The method according to claim 8, wherein the injector is removed from its packaging during a preliminary step.
 10. The method according to claim 8, wherein a viscoelastic solution is introduced within the lens compartment prior to step b).
 11. An injector for folding and injecting into an eye of a patient a flexible intraocular lens, the injector comprising: an injection nozzle; a support guide around the injection nozzle; a lens support in the support guide; an injector body communicating with the support guide; a plunger inserted in a free end of the injector body; and a plunger guide disposed within the injector body with its distal end contacting the lens support, the plunger movable in a longitudinal direction of the injector body, wherein the plunger guide is reversibly attached to and moves in the longitudinal direction of the injector body with the plunger when the plunger is moved over a first distance in the longitudinal direction of the injector body whereby the lens support is advanced within the support guide, and detaches from the plunger when the plunger is moved further over a second distance in the longitudinal direction of the injector body, the plunger being able to move freely within the plunger guide.
 12. The injector according to claim 11, wherein the plunger guide comprises a pair of flexible legs connected on a distal side of the plunger guide by a connecting portion, a free end of each leg comprising a stop piece, and wherein the plunger comprises clipping means, able to clip on the stop pieces when the legs are in a closed position, attaching the plunger to the plunger guide, and able to be unclipped when the legs are in an open position, detaching the plunger from the plunger guide.
 13. The injector according to claim 12, wherein the clipping means are two opposite snap hooks able to engage on distal edges of the stop pieces.
 14. The injector according to claim 12, wherein the injector body comprises a first portion and a second portion, the legs of the plunger guide being in the closed position when the plunger guide is at least partly positioned within the second portion, and the legs being in the open position when the plunger guide is positioned completely within the first portion.
 15. The injector according to claim 14, wherein a length of the second and first portion corresponds, respectively, to the first and second distance.
 16. The injector according to claim 14, wherein an internal section of the second portion is such as to force the legs of the plunger guide to be in the closed position and the first portion has an internal section larger than the one of the second portion allowing the legs to regain their unstressed open position.
 17. The injector according to claim 11, wherein a plug is held at a distal end of the plunger, the plug being able to drive the lens when the plunger is moved over the second distance.
 18. The injector according to claim 17, wherein the plug is made from a soft and flexible material.
 19. The injector according to claim 17, wherein the distal end of the plunger has a shape of a two-toothed fork destined to hold the plug.
 20. The injector according to claim 11, wherein the plunger guide extends in a longitudinal direction of the injector body and is spaced from the plunger in a radial direction.
 21. An injector for folding and injecting into an eye of a patient a flexible intraocular lens, the injector comprising: an injection nozzle; a support guide around the injection nozzle; a lens support having a pair of parallel plates and a pair of folding members, each folding member attached at an end of one of the pair of parallel plates; a lens compartment in communication with the injection nozzle; and an injector body communicating with the lens compartment and a plunger that is inserted in a free end of the injector body; the plunger extending through the injector body; wherein the support guide presses the pair of folding members inward toward a longitudinal axis of the plunger to compress a lens, wherein the support guide comprises two sloped ridges destined to cooperate with the pair of folding members, forcing the pair of folding members to fold until they become essentially parallel to the longitudinal axis of the plunger, and wherein the sloped ridges force the folding members to be between the pair of parallel plates. 